MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,study report with the FDA on 2019-09-12 for PERSONA? VIVACIT-E? N/A 42512400711 manufactured by Zimmer Orthopaedic Mfg. Ltd..
[160440481]
(b)(4). Concomitant medical product: femur cemented posterior stabilized (ps) standard left size 7 catalog 42500606201 lot 64186094; natural tibia cemented 5 degree stemmed left size e catalog 42532007101 lot 64293425; all poly patella cemented 32 mm diameter catalog 42540000032 lot 64197081, the product will not be returned to zimmer biomet for investigation as it remains implanted. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[160440482]
It was reported post knee arthroplasty the patient experienced procedure related complication of electrolyte imbalance of low sodium level, which required medical intervention and increased the patient? S hospital length of stay.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007963827-2019-00262 |
| MDR Report Key | 9012042 |
| Report Source | HEALTH PROFESSIONAL,STUDY |
| Date Received | 2019-09-12 |
| Date of Report | 2019-09-12 |
| Date of Event | 2019-08-13 |
| Date Mfgr Received | 2019-08-21 |
| Device Manufacturer Date | 2019-05-13 |
| Date Added to Maude | 2019-09-12 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. CHRISTINA ARNT |
| Manufacturer Street | 56 E. BELL DR. |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal | 46582 |
| Manufacturer Phone | 5745273773 |
| Manufacturer G1 | ZIMMER ORTHOPAEDIC MFG. LTD. |
| Manufacturer Street | BUILDING NO 2 EAST PARK SHANNON INDUSTRIAL ESTATE |
| Manufacturer City | SHANNON, COUNTY CLARE |
| Manufacturer Country | EI |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PERSONA? VIVACIT-E? |
| Generic Name | PROSTHESIS, KNEE |
| Product Code | OIY |
| Date Received | 2019-09-12 |
| Model Number | N/A |
| Catalog Number | 42512400711 |
| Lot Number | 64281984 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER ORTHOPAEDIC MFG. LTD. |
| Manufacturer Address | BUILDING NO 2 EAST PARK SHANNON INDUSTRIAL ESTATE SHANNON, COUNTY CLARE EI |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2019-09-12 |